← Back to catalogue
Iplan Rt Dose, Iplan Rt Adaptive, Iplan Rt Phantom Qa, Iplan Rt Review
FDA UDIClass II (US FDA UDI)
by Brainlab SE
Identity
- Trade Name
- Iplan Rt Dose, Iplan Rt Adaptive, Iplan Rt Phantom Qa, Iplan Rt Review FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Model / Reference
- 4.5 FDA UDI
Identifiers
- Catalog Number
- 21381E FDA UDI
- Primary DI / UDI-DI
- 04056481000592 FDA UDI
- 510(k) Number
- K080888 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Iplan Rt Dose, Iplan Rt Adaptive, Iplan Rt Phantom Qa, Iplan Rt Review by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K080888 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
Sources (1)
- FDA UDI 8a6e665e-d6ed-48a7-8ed7-1c61eeb685b1 36 fields · synced May 30, 2026